MAUDE Adverse Event Report: COOK INC. FLEXOR URETERAL ACCESS SHEATH AND DILATORS; FED, ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Model Number	G34880
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: phone: (b)(6).E3: occupation: quality specialist.H3: device evaluation anticipated, but not yet begun.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It was reported a male patient of undisclosed age underwent a flexible ureteroscopy-lithotripsy procedure in which the flexor ureteral access sheath and dilators were used.While removing stone fragments, the surgeon noticed that fragments of the inner part of the sheath were coming loose.The surgeon removed the fragments and the sheath at the end of the procedure, replacing it with another.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.

• Brand Name: FLEXOR URETERAL ACCESS SHEATH AND DILATORS
• Common Device Name: FED, ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 23451124
• Report Number: 1820334-2025-01355
• Device Sequence Number: 15705381
• Product Code: FED
• UDI-Device Identifier: 00827002348806
• UDI-Public: (01)00827002348806(17)280109(10)16412804
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K172217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G34880
• Device Catalogue Number: FUS-107045
• Device Lot Number: 16412804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 07/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLEXOR URETERAL ACCESS SHEATH AND DILATORS; MOTION¿ HYBRID WIRE GUIDE; NCIRCLE® NITINOL TIPLESS STONE EXTRACTOR; URF WESEEMED
• Patient Sex: Male